Clinical trial · Interventional
Stereotactic Body Radiation Therapy (SBRT) Efficiency and Toxicity in Liver Cancer
Phase II Study, Stratified, Non-randomized, Estimating SBRT Efficiency and Toxicity in Primary and Secondary Liver Tumors
NCT03408665CI-TRIAL-00106725STEREOLIVERactive not recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Intervention research involving the human person, phase II, prospective, multicentric, non-randomized and multi-cohort study. The eligibility criteria are broad, on purpose, so every patient, able to be treated by SBRT and unable to participate in another trial (non eligible patient or non included centers), can be included in this national study, in a prospective way.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Liver Cancer | Malignant Liver Neoplasm | CURATED_EXACT | 0.92 |
| Liver Metastases | Liver Neoplasm | PROBABILISTIC | 0.70 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| SBRT | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- SBRT
- description
- Stereotaxic Body Radiation Therapy administred in 3 to 6 fractions.
- interventionNames
- Radiation: SBRT
Primary outcomes (1)
- measure
- SBRT efficiency in term of L-PFS for patient who are to be treated with SBRT in patients with primitive hepatic tumor of hepatic metastatis
- timeFrame
- From baseline to 36 months following up.
- description
- Local progression-free survival (L-PFS) thanks to Kaplan-Meier method from registration date to date of local progressive disease.
Secondary outcomes (12)
- measure
- Estimate the SBRT efficiency in a prospective way, in term of local progression-free survival (L-PFS) for patient treated with SBRT in the 4 considered clinical situations.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Age ≥ 18 years old * With primary or secondary liver tumor and matching one of the following situations: * Liver Metastasis (LM): anatomopathologic diagnosis of the primary tumor * Hepatocellular Carcinoma (HCC): diagnosis achieved through biopsy or through non-invasive methods approved by AASLD criteria (Bruix, 2011) * Cholangiocarcinoma (CC): diagnosis achieved through biopsy * Other primitive hepatic tumor achieved through biopsy * Meet the requirements for SBRT treatment: * Liver Metastasis (LM): oligometastatic disease * Hepatocellular Carcinoma (HCC): non eligible lesion to curative surgery * Cholangiocarcinoma (CC): nodular lesion * Other primitive hepatic tumor: non eligible lesion to curative surgery * Able to receive a SBRT treatment according to the multidisciplinary consultation meeting * Tumor assessable with CT-scan or MRI according to mRECIST in HCC or Recist 1.1 in other situations * Affiliation to the National Social Security System * With informed and signed consent Exclusion Criteria: * Eligibility to a curative surgery according to the multidisciplinary consultation meeting * Contraindication to SBRT (especially Cirrhose Child C) * Pregnant or breastfeeding women * Patient Under guardianship or tutorship * Impossibility to submit at the study procedures due to geographic, social or mental reasons
References
Publications (0)
Data not yet available
No reference posted for this study.